Scientist IV - Analytical Development, Biologics CMC

SUMMARY/JOB PURPOSE:

The Scientist IV, Analytical Development, Biologics CMC will independently conduct laboratory experiments with limited supervision to build in-house R&D testing capabilities in support of CMC analytical development projects for multiple types of biologics, including but not limited to antibody-drug conjugates (ADCs), monoclonal antibodies (mAb), and bispecifics (BsAb). The incumbent will utilize their technical expertise in analytical areas such as liquid chromatography (e.g., SEC, RP, HIC, IEX), capillary electrophoresis (e.g., CE-SDS and icIEF), mass spectrometry, or potency methods to execute method development and product characterization. The incumbent is expected to work in the laboratory full time, including operating state-of-art analytical equipment, responsible for routine instrument maintenance, and providing training to peers. The incumbent is also expected to effectively document lab results and draft test methods/SOPs in accordance with company, departmental, and regulatory guidelines.

Strong ownership is critical to ensure the speed, cost-effectiveness, and technical quality of our CMC activities. The individual selected will also need to work collaboratively with peers in an open well-equipped analytical lab.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Execute and develop analytical methods for ADCs, mAb, and BsAb analyses, such as SEC, RP, HIC, IEC, Polysorbate, Glycan, CE-SDS, icIEF, etc.
• Execute and develop mass spectrometry or ELISA based activity methods as needed.
• Maintain complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training.
• Perform sample testing to support the internal and external product development activities.
• Provide detailed reviews of peer generated data as well as that generated from contracted service providers.
• Maintain the inventory of laboratory consumables and clean glassware.
• Coordinate vendors service calls for repair and maintenance of laboratory instruments, perform routine maintenance of laboratory instrumentation, and maintain complete and accurate records of instrument service and repairs in conformance with company SOPs and policies.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 5 years of relevant industry experience; or,
• Master's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 3 year of relevant industry experience; or,
• Equivalent combination of education and experience.

Experience:

• Demonstrated development expertise in separation sciences for the analysis of ADC, mAb, or BsAb, such as DAR, free drug related impurities, SEC, RP, HIC, IEC, Polysorbate 80/20, Glycan, icIEF and CE-SDS.
• Experience in protein structural elucidation and peak identification using high-resolution mass spectrometry is a plus.
• Experience in ELISA or cell-based assays is a plus.

Knowledge/Skills:

• In-depth knowledge of a broad range of analytical methods.
• Ability to collaborate with peers and cross-functional teams.
• Ability to multi-task in a fast-paced dynamic environment while delivering high-quality work.
• Good interpersonal, presentation, and written communication skills
• Working knowledge of cGMP environment is a plus.

SUPERVISORY RESPONSIBILITIES:

• None

WORKING CONDITIONS:

• Environment: primarily working in laboratories
• Exposures encountered, such as hazardous materials, and extreme cold.
• Limited travel requirement

#LI-MB1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $100,000 - $141,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.